(59 days)
The MOSS Miami Spinal System is intended for non-cervical use in the spine.
When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.
The provided text is a 510(k) summary for the DePuy Motech MOSS Miami Spinal System and a clearance letter from the FDA. It does not describe any specific acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures typically associated with modern medical device studies, particularly for AI/software devices.
Instead, the document focuses on the regulatory acceptance of the device based on its substantial equivalence to previously cleared predicate devices. The "acceptance criteria" here are essentially the FDA's requirements for demonstrating substantial equivalence for marketing.
Here is a breakdown of the requested information based on the provided text, noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Clearance) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| General Use (anterior screw fixation or posterior hook, non-pedicle screw fixation): | Intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies). |
| Pedicle Screw Fixation Use (Specific Limitations): | Intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass. |
| Substantial Equivalence: | Components are identical to components of other MOSS Miami Spinal Systems previously cleared by FDA for anterior, posterior, and pedicle fixation uses. An insertion tool has been included for ease of implantation. |
| Regulatory Compliance: | - Required annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration (General Controls). |
- All labeling must state explicit limitations for pedicle screw use as described in the letter.
- No labeling or promotion for pedicular screw fixation/attachment other than severe spondylolisthesis (Grades 3 and 4 L5-S1).
- Specific warnings must be included in the package insert about pedicle screw use limitations and potential risks.
- Use for pedicular screw fixation for other indications is considered investigational and requires IDE regulations compliance.
- Compliance with Quality System Regulation (21 CFR Part 820). |
| Warning Statements: | Previous warning statements about components not approved for screw fixation into pedicles must be replaced by the specific warnings defined in the clearance letter. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not provided. The summary for this orthopedic implant device focuses on substantial equivalence based on design and material similarity to previously cleared devices, not on a clinical performance study with a "test set" in the context of a software or diagnostic device. No patient data or clinical study population is mentioned for performance evaluation in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable / Not provided. Ground truth establishment by experts is not described, as this is neither an AI device nor a diagnostic device that requires such evaluation in the context of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not provided. Adjudication methods are not relevant to this type of device submission as described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not provided. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not provided. This is an orthopedic implant, not an algorithm, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not provided. The "ground truth" here is regulatory acceptance based on substantial equivalence to predicate devices, not clinical truth derived from patient data.
8. The sample size for the training set
- Not Applicable / Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not provided. This is not an AI/ML device that requires ground truth for a training set.
Summary of the Document's Focus:
This 510(k) submission exemplifies a pre-AI era device clearance for an orthopedic implant. The "acceptance criteria" discussed are primarily regulatory in nature, focusing on:
- Demonstrating that the device (MOSS Miami Spinal System components) is "substantially equivalent" to predicate devices (other MOSS Miami Spinal Systems).
- Defining the specific "Indications for Use," particularly the stringent limitations for pedicle screw fixation.
- Ensuring appropriate labeling and warnings are in place to mitigate risks associated with the device, especially concerning pedicle screw use.
There is no mention of performance metrics (sensitivity, specificity, accuracy), clinical study results, or data analyses typical of AI/software medical devices. The "study" here is the submission itself, demonstrating compliance with regulatory standards for substantial equivalence, rather than a clinical trial proving a specific performance metric.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.